ammonia n 13
Ammonia N 13 (Ammonia N-13) is a radioactive diagnostic agent.
Ammonia N-13 · by Feinstein
Key facts
- Active ingredient
- Ammonia N-13
- Drug class
- Radioactive Diagnostic Agent
- Form
- Injectable, Solution
- Strength
- Ammonia N-13 30mCi-300mCi/8ML (3.75-37.5mCi/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Feinstein
- FDA application
- NDA022119
What is Ammonia N 13?
From the FDA label:11.1 Chemical Characteristics Ammonia N 13 Injection is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with positron emission tomography (PET) imaging. The active ingredient, [ 13 N] ammonia, has the molecular formula of 13 NH 3 with a molecular weight of 16.02, and has the following chemical structure: Ammonia N 13 Injection is provided as a ready to use sterile, pyrogen-free, clear, and colorless solution. Each mL of the solution contains between 0.138 GBq to 1.387 GBq (3.75 mCi to 37.5 mCi) of [ 13 N] ammonia, at the end of synthesis (EOS) reference time, in 0.9% aqueous sodium chloride. The pH of the solution is between 4.5 to 7.5. The recommended dose of radioactivity (10-20 mCi) is associated with a theoretical mass dose of 0.05-0.1 picomoles (8.47-16.94 picograms) of ammonia. NH3 Structure 11.2 Physical Characteristics Nitrogen N 13 decays by emitting positron to Carbon C 13 (stable) and has a physical half-life of 9.96 minutes. The principal photons useful for imaging are the dual 511 keV gamma photons that are produced and emitted simultaneously in opposite direction when the positron interacts with an electron (Table 2). Table 2. Principal Radiation Emission Data for Nitrogen 13 Radiation/Emission % Per Disintegration Energy Positron(β+) 100 1190 keV (Max.) Gamma(±)* 200 511 keV *Produced by positron annihilation The…
How to use
Ammonia N 13 is sold in more than one form (Injectable and Solution), and each is dosed differently. The instructions below come from the FDA label for application NDA022119 — follow the label that came with the product you were actually prescribed.
Rest Imaging Study ( 2.1 ): • Aseptically withdraw Ammonia N 13 Injection from its container and administer 10-20 mCi (0.370 – 0.740 GBq) as a bolus through a catheter inserted into a large peripheral vein. • Start imaging 3 minutes after the injection and acquire images for a total of 10-20 minutes. Stress Imaging Study ( 2.2 ): • If a rest imaging study is performed, begin the stress imaging study 40 minutes or more after the first Ammonia N 13 Injection to allow sufficient isotope decay. • Administer a pharmacologic stress-inducing drug in accordance with its labeling. • Aseptically withdraw Ammonia N 13 Injection from its container and administer 10-20 mCi (0.370 – 0.740 GBq) of Ammonia N 13 Injection as a bolus at 8 minutes after the administration of the pharmacologic stress-inducing drug. • Start imaging 3 minutes after the Ammonia N 13 Injection and acquire images for a total of 10-20 minutes. Patient Preparation ( 2.3 ): • To increase renal clearance of radioactivity and to minimize radiation dose to the bladder, hydrate the patient before the procedure and encourage voiding as soon as each image acquisition is completed and as often as possible thereafter for at least one hour. 2.1 Rest Imaging Study • Aseptically withdraw Ammonia N 13 Injection from its container and administer 10-20 mCi (0.370 – 0.740 GBq) as a bolus through a catheter inserted into a large…
Side effects
No adverse reactions have been reported for Ammonia N 13 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. However, the completeness of these sources is not known. No adverse reactions have been reported for Ammonia N 13 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting system. To report SUSPECTED ADVERSE REACTIONS, contact The Feinstein Institutes for Medical Research at 516-562-1052 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Warnings
Important safety information
Ammonia N 13 Injection may increase the risk of cancer. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker. 5.1 Radiation Risks Ammonia N 13 Injection may increase the risk of cancer. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker [see Dosage and Administration ( 2.4 )] . 5.1 Radiation Risks Ammonia N 13 Injection may increase the risk of cancer. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker [see Dosage and Administration ( 2.4 )] .
Who should not take Ammonia N 13
None None
Interactions
The possibility of interactions of Ammonia N 13 Injection with other drugs taken by patients undergoing PET imaging has not been studied.
Drug class
How this class works, per Radionuclide Imaging in Cancer Medicine - Holland-Frei Cancer Medicine, NCBI Bookshelf.
Dosage forms
Injectable and Solution
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- How does Ammonia N 13 work?
- Ammonia N 13 is a radioactive diagnostic agent. A radioactive diagnostic agent is a small dose of a radioactive substance attached to a molecule that travels to a specific organ or tissue. Once there it gives off radiation that a scanner outside the body detects, producing images that show where that tissue is or how it is working.
- Is there a coupon or discount for Ammonia N 13?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Ammonia N 13. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Ammonia N 13?
- Ammonia N 13 is marketed by Feinstein. You can see Feinstein's full profile, rating, and other products on pharmaranks.
- Is Ammonia N 13 a brand-name or generic drug?
- Ammonia N 13 is a brand-name product with the active ingredient Ammonia N-13.
- Is Ammonia N 13 available over the counter?
- No. Ammonia N 13 is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Ammonia N 13 come in?
- Ammonia N 13 is currently marketed as injectable and solution, per the FDA's National Drug Code Directory.
- What class of drug is Ammonia N 13?
- Ammonia N 13 is classified as radioactive diagnostic agent, per the FDA's Established Pharmacologic Class.
- Is Ammonia N 13 FDA-registered?
- Ammonia N 13 is on record with the U.S. FDA under application number NDA022119. You can verify this on its official FDA label.
- Is Ammonia N 13 safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Ammonia N 13. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Ammonia N 13?
- Ammonia N 13's side effects are taken directly from its FDA label. From the label: No adverse reactions have been reported for Ammonia N 13 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. However, the completeness of these sources is not known.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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